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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.319 |
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A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium - Sugammadex | Active Comparator | Rocuronium - Sugammadex 4.0 mg/kg |
|
| Succinylcholine | Active Comparator | Succinylcholine 1.0 mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rocuronium | Drug | A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 5 minutes post dose |
| Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex | Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 5 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25768376 | Result | Soto R, Jahr JS, Pavlin J, Sabo D, Philip BK, Egan TD, Rowe E, de Bie J, Woo T. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial. Am J Ther. 2016 Nov/Dec;23(6):e1654-e1662. doi: 10.1097/MJT.0000000000000206. | |
| 24710957 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium - Sugammadex | An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| sugammadex | Drug | At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered. |
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| succinylcholine | Drug | A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade. |
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| Baseline and 2 minutes post dose |
| Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex | Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 2 minutes post dose |
| Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 10 minutes post dose |
| Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex | Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 10 minutes post dose |
| Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 15 minutes post dose |
| Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex | Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Baseline and 15 minutes post dose |
| Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups | Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered "pretreatment" events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure). | Up to 7 days post dose |
| Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium | Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. | Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes) |
| Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine | Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice. | Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes) |
| Sabo D, Jahr J, Pavlin J, Philip B, Shimode N, Rowe E, Woo T, Soto R. The increases in potassium concentrations are greater with succinylcholine than with rocuronium-sugammadex in outpatient surgery: a randomized, multicentre trial. Can J Anaesth. 2014 May;61(5):423-32. doi: 10.1007/s12630-014-0128-7. Epub 2014 Apr 8. |
| Succinylcholine |
An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium - Sugammadex | An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade. |
| BG001 | Succinylcholine | An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Includes only participants who were randomized and treated with sugammadex or succinylcholine | Mean | Standard Deviation | years |
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| Sex: Female, Male | Includes only participants who were randomized and treated with sugammadex or succinylcholine | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 5 minutes post dose |
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| Secondary | Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 2 minutes post dose |
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| Secondary | Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex | Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 2 minutes post dose |
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| Secondary | Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 10 minutes post dose |
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| Secondary | Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex | Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 10 minutes post dose |
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| Secondary | Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine | Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 15 minutes post dose |
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| Secondary | Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex | Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 15 minutes post dose |
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| Primary | Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex | Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period). | Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 5 minutes post dose |
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| Secondary | Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups | Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered "pretreatment" events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure). | Participants who received sugammadex or succinylcholine. | Posted | Number | participants | Up to 7 days post dose |
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| Secondary | Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium | Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. | Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee. | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes) |
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| Secondary | Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine | Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice. | Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee. | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes) |
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Up to 7 days post dose
Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rocuronium - Sugammadex | An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade. | 1 | 66 | 57 | 66 | ||
| EG001 | Succinylcholine | An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade. | 3 | 80 | 67 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (12.1) |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (12.1) |
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| Medical observation | Investigations | MedDRA (12.1) |
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| Oxygen saturation decreased | Investigations | MedDRA (12.1) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) |
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| Nausea | Gastrointestinal disorders | MedDRA (12.1) |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.1) |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA (12.1) |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (12.1) |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (12.1) |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (12.1) |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) |
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The potassium change from baseline interval included most/all of the intubation/surgical period for the sug but not the suc or roc analysis. AE reporting interval included the entire intubation/surgery period for the suc but not the roc-sug group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D000077122 | Sugammadex |
| D013390 | Succinylcholine |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
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| Units | Counts |
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